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FDA 510(k)

FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)

K-Number: K964892 · 1997-02-04

ApplicantGynecare Innovation Center
Decision Date1997-02-04
Product CodeFJL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare Innovation Center. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K964892. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)?

FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Gynecare Innovation Center. The 510(k) number is K964892.

When did FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) receive FDA 510(k) clearance?

FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) received FDA 510(k) clearance on 1997-02-04, under 510(k) number K964892.

Who is the listed applicant for FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)?

The FDA 510(k) record lists Gynecare Innovation Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY)?

The FDA product code for FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) is FJL.

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Other records listing Gynecare Innovation Center as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K980393SOPRANO CRYO-THERAPY SYSTEMK971305FEMRX FOCUSED MONOPOLAR (FMP) OPERA STAR SYSTEMK964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND ABLATION (OPERA)] [SPECIALIZED TISSUK963872FEMRX MORCELLATOR SYSTEMK962506[SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)]K954775FLO-STAT FLUID MONITORING SYSTEM

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Related Devices (Code: FJL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KGK221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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